The documentation has been developed to ensure that the initiative gains as much advantage from the IAF MLA as possible by ensuring that accredited certificates issued to ISO 13485 are able to include the IAF MLA Mark, which is the IAF MLA?Mark in combination with the symbol of the accreditation body. The IAF MLA Mark will not appear on certificates on its own.

The IAF MLA mark’s appearance on an ISO 13485 Certificate assures the user of the certificate that the ISO 13485 audit is highly credible and operating under IAF MLA Management.

To ensure that the IAF MLA Mark may be used on accredited certificates, the initiative has been endorsed by the IAF in accordance with the document IAF PL3.

The IAF MLA mark can be used by accreditation bodies to demonstrate their status as a signatory to the IAF MLA. Accredited certification bodies can also use the mark in combination with the accreditation symbol on their certificates providing they are issued in association with IAF endorsed normative documents such as ISO 13485.

The Mark demonstrates that the certificate has been issued by a certification body that is accredited by an IAF MLA member and is thus traceable to the highest authority. It is an assurance that the certificate and the issuing body are of a high standard of competence and may be trusted, as they are recognised as complying to the same set of standards at the global level.

Key Features of the Initiative

The relationship of Risk Classification of Medical Devices to QMS requirements

The significance of risk classification to the QMS is that based on whether the medical device is higher or lower risk, the regulator may or may not require the manufacturer’s quality management system to be independently certified to ISO 13485. The purpose of classification is to match regulatory oversight and market clearance to the level of risk of the device’s risk. Lower risk medical devices usually do not require independent certification of the manufacturer’s QMS.

The illustration below is a very basic example of how ISO 13485 certification could be applied to four different risk classifications for medical devices:

Two approaches to that are widely used to determine risk classification:

Risk classification rules

Risk “classification rules” use general principles of risk, related to patient contact with energy, substances, invasiveness into the body, as well as other criteria, to determine the risk level of a medical device. Higher risk devices have a contact with the body for a longer time period than lower risk devices. They are more invasive inside the body or rely on a more hazardous energy sources. Several risk rules can be found to apply to one medical device. It is the responsibility of the manufacturer to apply the higher risk classification when more than one risk classification is identified using applicable risk rules. A full list of risk classification rules can be viewed in the GHTF document SG1-N15: 2006 - “Principles of Medical Devices Classification”.

Risk classification names

Risk classification names appear as an assigned risk classification next to the name of the medical device type (e.g. Blood Pressure Cuff - Class B). The Medical Devices risk classifications are then made public and allow the regulatory authority to adjust the risk classification more easily, if post market experience shows a particular product to be more, or less safe than originally thought. Changing a risk classification for one product, does not change the risk classification of another. Risk classifications may be assigned by consensus from a group of medical device experts. Some medical device experts use risk classification rules to assign the first risk classification for a new type of medical device.

Although the IAF initaitive for ISO 13485 does not prescribe any risk classification system, requirements for ISO 13485 certification should be based on the risk of a device to public health.